A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
Public ClinicalTrials.gov record NCT00664768. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, DB Controlled Study to Evaluate the Nutritional Safety (Growth) of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA. This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.
Study identification
- NCT ID
- NCT00664768
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 126 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Day to 8 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2008
- Primary completion
- Jun 30, 2012
- Completion
- Jun 30, 2012
- Last update posted
- Dec 8, 2020
2008 – 2012
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pendleton Pediatrics | Chandler | Arizona | 85224 | — |
| Visions Clinical Research - Tucson | Tucson | Arizona | 85712 | — |
| Children's Investigational Research Program, LLC (CHIRP) | Bentonville | Arkansas | 72712 | — |
| Children's Hospital, LA | Los Angeles | California | 90027 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | — |
| Rosario B. Retino, MD, Inc | Ontario | California | 91762 | — |
| Choc Psf, Amc | Orange | California | 92868 | — |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | — |
| Alzein Pediatrics | Evergreen Park | Illinois | 60805 | — |
| Regional Research Specialists, LLC | Shreveport | Louisiana | 71106 | — |
| Craig A. Spiegel, M.D. | Bridgeton | Missouri | 63044 | — |
| Meridian Clinical Research, LLC | Omaha | Nebraska | 68134 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Asheboro Research Associates | Asheboro | North Carolina | 27203 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Pediatrics, PLLC | Holly Springs | North Carolina | 27540 | — |
| John Panuto, M.D. | Middleburg Heights | Ohio | 44130 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Childrens Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| PI-Coor Clinical Research, LLC | Burke | Virginia | 22015 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23219 | — |
| Advanced Pediatrics | Vienna | Virginia | 22180 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00664768, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 8, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00664768 live on ClinicalTrials.gov.